SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM
FDA premarket approval P030011/S036 · decided 2015-12-09
Approval details
- PMA number
- P030011
- Supplement
- S036
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM
- Generic name
- Artificial heart
- Applicant
- Syncardia Systems, LLC
- Date received
- 2015-10-19
- Decision date
- 2015-12-09
- Days to decision
- 51 days
- Decision code
- APPR
- Product code
- LOZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- APPROVAL FOR THE ADDITION OF TWO WARNINGS TO THE COMPANION 2 DRIVER SYSTEM OPERATOR MANUAL.
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